NDC codes

FDA NDC Directory
Product NDC (as listed)70518-2755Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-2755Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70518-2755-0705182755007051827550030 TABLET in 1 BLISTER PACK (70518-2755-0)Marketed from May 26, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Lamotrigine
Generic name (nonproprietary)
lamotrigine
Active ingredients
Lamotrigine — 25 mg/1
Dosage form
Tablet
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078947
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)Dihydrofolate Reductase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)
Identifiers
Product ID 70518-2755_57b03fbe-2936-e804-e063-6294a90a4b3aSPL ID 57b03fbe-2936-e804-e063-6294a90a4b3aSPL set ID 1d7c2d52-a78e-4508-8853-ba306cdeeabaRxCUI 282401UNII U3H27498KS
Pharmacologic class
Anti-epileptic Agent; Mood Stabilizer

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N470518275500 followed by a unit qualifier and the quantity

Package 70518-2755-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

Lamotrigine tablet is indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. ( 1.1 ) Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. ( 1.1 ) Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. ( 1.2 ) Limitations of Use…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-2755

What is NDC 70518-2755?
70518-2755 is the product NDC for Lamotrigine, Lamotrigine 25 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Lamotrigine.
What is the active ingredient?
Lamotrigine.
Who is the labeler?
REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lamotrigine?
262 other product NDCs are listed under this name. See all Lamotrigine NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Lamotrigine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LamotrigineLamotrigine 50 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-470270518-4702-00
LamotrigineLamotrigine 25 mg/1TabletOralCoupler LLC67046-035867046-0358-03
LamotrigineLamotrigine 150 mg/1TabletOralCoupler LLC67046-074967046-0749-03
LamotrigineLamotrigine 100 mg/1TabletOralCoupler LLC67046-035967046-0359-03
lamotriginelamotrigine extended-releaseLamotrigine 200 mg/1Tablet, Film coated, Extended releaseOralREMEDYREPACK INC.70518-463870518-4638-00
LamotrigineLamotrigine 25 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Inc.62332-77062332-0770-1562332-0770-30
LamotrigineLamotrigine 50 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Inc.62332-77162332-0771-1562332-0771-30
LamotrigineLamotrigine 100 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Inc.62332-77262332-0772-1062332-0772-30
LamotrigineLamotrigine 200 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Inc.62332-77362332-0773-1062332-0773-30
LamotrigineLamotrigine 25 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Limited46708-77046708-0770-1546708-0770-30

All 263 Lamotrigine NDCs

Other NDCs under ANDA 078947

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078947
ProductStrengthForm · routeLabelerProduct NDC
LamotrigineLamotrigine 25 mg/1TabletOralTorrent Pharmaceuticals Limited13668-045
LamotrigineLamotrigine 100 mg/1TabletOralTorrent Pharmaceuticals Limited13668-047
LamotrigineLamotrigine 150 mg/1TabletOralTorrent Pharmaceuticals Limited13668-048
LamotrigineLamotrigine 200 mg/1TabletOralTorrent Pharmaceuticals Limited13668-049
Lamotrigine—KitTorrent Pharmaceuticals Limited13668-266
LamotrigineLamotrigine 100 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-203
LamotrigineLamotrigine 25 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-238
LamotrigineLamotrigine 200 mg/1TabletOralA-S Medication Solutions50090-6028
LamotrigineLamotrigine 25 mg/1TabletOralNorthwind Health Company, LLC51655-855
LamotrigineLamotrigine 100 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3607
LamotrigineLamotrigine 25 mg/1TabletOralOWP Pharmaceuticals, Inc.69102-639
LamotrigineLamotrigine 100 mg/1TabletOralREMEDYREPACK INC.70518-2889
LAMOTRIGINE Kitlamotrigine—KitOWP Pharmaceuticals, Inc.69102-137
LAMOTRIGINE Kitlamotrigine—KitOWP Pharmaceuticals, Inc.69102-359
SubvenitelamotrigineLamotrigine 150 mg/1TabletOralOWP Pharmaceuticals, Inc.69102-150
Subvenitelamotrigine—KitOWP Pharmaceuticals, Inc.69102-300
SubvenitelamotrigineLamotrigine 25 mg/1TabletOralOWP Pharmaceuticals, Inc.69102-301
Subvenitelamotrigine—KitOWP Pharmaceuticals, Inc.69102-306
Subvenitelamotrigine—KitOWP Pharmaceuticals, Inc.69102-312
SubvenitelamotrigineLamotrigine 100 mg/1TabletOralOWP Pharmaceuticals, Inc.69102-319

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